One-Time Miracle Drug Pulled from Store Shelves

by | Nov 24, 2021 | Injuries

Following reports of life-threatening contamination, the Food and Drug Administration recalled one of the only drugs which effectively treats a rare childhood disease.

According to laboratory tests, three lots of Ruzurgi had high levels of mold, yeast, and bacteria. The three contaminated lots all had 2023 expiration dates. As a precaution, the company is removing Ruzurgi from circulation worldwide.

New Jersey-based Jacobus Pharmaceuticals originally gave Rugzurgi away for free when it was initially approved in the 1990s.

LEMS Disease and Available Medications

Lambert-Eaton Myasthenic Syndrome is a very rare autoimmune disease which is found mostly in children between 7 and 17. ABout half of LEMS cases are connected with cancer, mostly lung cancer. In an over-aggressive attempt to fight cancer cells, antibodies attack certain nerve endings which are chemically similar to cancer cells. In the other half of LEMS cases, the cause is completely unknown.

This disease causes muscle weakness all over the body, but especially in the thighs, neck, face, and shoulders. There is no cure. Medication only treats the symptoms. 

Ruzurgi (amifampridine) is the only voltage-gated calcium channel (VGCC) blocker approved for children. Blocking this channel slows or prevents the nerve cells from “resetting” after sending a signal to the muscles. So, nerve cells send longer-lasting nerve impulses, which leaves the remaining VGCC open longer. This increases the signal that nerve cells send to the muscles and can help compensate for the lower number of VGCCs in LEMS. A similar medication, Firdapse (amifampridine phosphate), is only approved for adults. Furthermore, it’s harder to store than Ruzurgi.

Parents with LEMS children might be tempted to use Firdapse. Such use is legal, because once the FDA approves a drug, it approves it for all purposes. In fact, such off-label use is common. It’s also dangerous.

The InFuse Bone Graft is a good example. This device, which stimulates bone growth, is mostly used in certain spinal fusion surgeries. However, according to company promotions, the device was also useful in experimental dental surgery. Medtronic, the device’s manufacturer, sponsored lavish “seminars” in exoctic locations which instructed dentists in this experimental use. Many patients were injured as a result.

Product Defects

If your child got an infection from taking Ruzurgi, you might be entitled to compensation from the manufacturer. Usually, companies are strictly liable for the injuries their defective products cause. So, a Lexington personal injury attorney must only show that there was a connection between the medication and the injury. A time connection is usually sufficient.

Frequently, a manufacturing defect causes medicine contamination. Drug manufacturers often take dangerous shortcuts during the manufacturing process. Often, they view quality control as an unnecessary cost. Ruzurgi is just one example. Zantac is a better example. When this drug is shipped and stored at room temperature, per the manufacturer’s instructions, NDMA, one of the world’s most dangerous carcinogens, contaminates it.

Sometimes, a design defect is the problem. The 1970s Ford Pinto is the classic example. As a cost-cutting move, designers placed the Pinto’s unprotected gas tank near the rear bumper. So, the gas tank often ruptured and exploded even in low-speed collisions. Ford executives concluded that settling lawsuits, and killing people, was cheaper than fixing the problem.

Regardless of the underlying cause, manufacturers have a duty to warn consumers about all known risks, no matter how unlikely the side-effects are. But manufacturers usually don’t issue specific warnings. They are afraid that the negative information might suppress sales. And in the pharmaceutical area, money is all that matters.

Your Claim for Damages

Dangerous drugs usually affect thousands of people. Normally, such claims become class action claims. But due to their unique nature, courts usually create Multi-District Litigation forums for dangerous drug claims. 

Similar dangerous drug cases from all over the country are consolidated in one location for pretrial purposes. MDL conserves judicial resources. Furthermore, the judge in charge usually appoints a special master to oversee these cases. This person is usually a products liability attorney who understands the technical and scientific issues involved in these cases.

MDL has specific benefits for victims. Different victims consolidate their resources. It’s much easier for a group of Davids to take on a single Goliath. Furthermore, once one claim settles, the resolution creates settlement momentum across the board. Alternatively, manufacturers might create one large settlement fund which is easy for victims to access.

Injury victims are usually entitled to substantial compensation. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. We do not charge upfront legal fees in these matters. #goodelawyers